Testosterone Cypionate

Product NDC: 0591-4128
Requested package NDC: 0591-4128-79
11-digit product format: 005914128
Labeler code: 0591
Product ID: 0591-4128_29a2173d-d9b2-467b-94ea-a0041e8c951f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Testosterone Cypionate
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Actavis Pharma, Inc.
Application: ANDA091244
Marketing category: ANDA
Marketing start: 2015-03-05
Marketing end: 0000-00-00
Substance: TESTOSTERONE CYPIONATE
Active strength: 200 mg/mL
Pharmacologic classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0591-4128	0591-4128-79	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-4128	0591-4128-79	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-4128	0591-4128-79	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091244-001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO		2012-05-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A091244-001	AO

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091244-001	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091244-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091244-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091244-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091244-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091244-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091244-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091244-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091244-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091244-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091244-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091244-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091244-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091244-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091244-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091244-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091244-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091244-001	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091244-001	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091244-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091244-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091244-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091244-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091244-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091244-001	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091244-001	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091244-001	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091244-001	AO	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091244-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091244-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091244-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091244-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091244-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091244-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091244-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091244-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091244-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091244-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091244-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091244-001	AO	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-4128-79	ML - Milliliter	0591-4128	6cafa2f2-48ec-4ed7-8979-47a4ccd35751	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TESTOSTERONE CYPIONATE	ACTIVE INGREDIENT	M0XW1UBI14	TESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]	6
TESTOSTERONE	ACTIVE MOIETY	3XMK78S47O	TESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]	6
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	TESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]	6
BENZYL BENZOATE	INACTIVE INGREDIENT	N863NB338G	TESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]	6
COTTONSEED OIL	INACTIVE INGREDIENT	H3E878020N	TESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-4128	TESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]	13	Legacy NDC	20230420_d7b57b68-dca6-4df2-b3f2-7017d7b69f17.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Testosterone Cypionate	TESTOSTERONE CYPIONATE	ASCLEMED USA INC.	4efcb0be-a19b-4c6b-8a42-cd52a40d095b	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	ad65b1ec-433e-4524-924e-ebad09762126	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	327b4357-6948-4cd6-ad6c-e463ab8600ad	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Cipla USA Inc.	b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c478	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hikma Pharmaceuticals USA Inc.	f60c5520-b336-44a2-95d5-f274939fa595	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hikma Pharmaceuticals USA Inc.	5ca67491-4b30-4a47-af0a-be250215d1f0	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	A-S Medication Solutions	47df0787-af81-43ca-bd67-1b5d127ff3c3	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	9d0a1923-be39-41d9-8183-706b227f615c	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	8699c6cb-fede-43ea-ad5e-817700fa7a82	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	3b0c61de-8cfa-4f76-b07c-0d3b7704b642	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Padagis US LLC	e3e2da65-4b2a-4210-a6ff-cc08c8567381	2021-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Proficient Rx LP	6bb7d3cc-2b5a-4a48-858e-5421c68b6989	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Proficient Rx LP	2db0a398-5512-431c-a952-b0290d4fe2d9	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M0XW1UBI14	TESTOSTERONE CYPIONATE	58-20-8	TESTOSTERONE CYPIONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-4128-79	00591412879	10 mL in 1 VIAL (0591-4128-79)	10 ml	2015-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TESTOSTERONE CYPIONATE INJECTION, USP Rx Only	Actavis Pharma, Inc.	2018-10-31	HUMAN PRESCRIPTION DRUG LABEL	13